Clinical trial · Interventional
Metabolic Interventions (Time-Restricted Eating, GLP1 Receptor Agonist, and Heart Healthy Diet) to Improve Cardiometabolic Health in Prostate Cancer Patients During Androgen Deprivation Therapy, IMPACT-ADT Trial
A Phase II Randomized Study of Interventions for Metabolic Protection Against Cardiometabolic Toxicity During Androgen Deprivation Therapy (IMPACT-ADT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial compares the effect of time-restricted eating (TRE) and glucagon-like peptide-1 (GLP1) receptor agonists (RA), semaglutide and tirzepatide, to an American Heart Association (AHA) heart healthy diet (HHD) intervention on heart and blood vessel health (cardiovascular system) and how the body processes food for energy (metabolic system) in prostate cancer patients undergoing androgen deprivation therapy (ADT). Prostate cancer patients who are receiving hormonal therapy (ADT) are at an increased risk of cardiovascular disease. This is thought to be due to treatment-related metabolic changes which may result in increased weight, body fat, insulin resistance and an increased risk of heart attack, stroke or other heart and blood vessel problems. TRE (also known as intermittent fasting) is an eating plan that alternates between fasting and non-fasting periods. This approach limits calorie intake to a specific window of time each day. GLP1-RAs, semaglutide and tirzepatide are in a class of medications called incretin mimetics. They work by helping the pancreas to release the right amount of insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy. They also slow the movement of food through the stomach and may decrease appetite and cause weight loss. The AHA HHD guidelines may be an effective method to help people learn about following a heart healthy eating plan. This may lower their risk of cardiovascular disease. Metabolic interventions, TRE and GLP1-RA, may be more effective than an AHA HHD intervention alone in improving cardiovascular and metabolic health in prostate cancer patients undergoing ADT.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (16)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antiandrogen Therapy | Drug | — | UNRESOLVED |
| Behavioral Intervention | Behavioral | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Cardiac Computerized Tomographic Angiography | Procedure | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Internet-Based Intervention | Other | — | UNRESOLVED |
| Lifestyle Counseling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1 (TRE)
- description
- Patients receive RT and ADT per SOC, as well as participate in an overnight fast over 16 hours on at least 5 days weekly for 6 months. Patients also receive TRE reminders, dietary education, and complete survey and food diary collection via the Oncpatient Companion Mobile app. In addition, patients receive diet/lifestyle counseling as per AHA HHD guidelines and AHA Life Essential 8 recommendations with personalized caloric intake for 6 months. Patients may may optionally wear an activity tracker throughout the trial. Additionally, patients undergo CT, blood sample collection throughout the study and may optionally undergo a coronary computerized tomography angiography throughout the study.
- interventionNames
- Drug: Antiandrogen Therapy
- Behavioral: Behavioral Intervention
- Procedure: Biospecimen Collection
- Procedure: Cardiac Computerized Tomographic Angiography
- Procedure: Computed Tomography
- Other: Electronic Health Record Review
- Other: Internet-Based Intervention
- Behavioral: Lifestyle Counseling
- Other: Medical Device Usage and Evaluation
- Other: Nutritional Intervention
- Other: Questionnaire Administration
- Radiation: Radiation Therapy
- Other: Short-Term Fasting
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Documented informed consent of the participant * English, Spanish or Mandarin-speaking * Agreement to allow the use of archival tissue from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Male * Aged: 30-79 * Eastern Cooperative Oncology Group (ECOG) 0-2 * High burden of cardiovascular comorbidities who would be eligible for insurance coverage for GLP1-RA therapy defined as: * Body mass index (BMI) of ≥ 30 kg/m\^2 or * BMI ≥ 27 kg/m\^2 in the presence of at least one weight-related comorbid condition (e.g. hypertension, type 2 diabetes mellitus, dyslipidemia) * Prostate cancer defined as one of the following: * National Comprehensive Cancer Network (NCCN) intermediate risk prostate cancer receiving definitive radiation with a plan to undergo ADT for 6 months * Biochemical persistent or recurrent prostate cancer status post prostatectomy receiving salvage radiation with a plan to undergo ADT for 6 months Exclusion Criteria: * Currently engaging in strict macronutrient/time limited diet, including ketogenic, low-carb, paleo, or warrior diet * Currently under GLP1-RA therapy * Poorly controlled diabetes * Unable to undergo time-restricted diet * Contraindications for GLP1-RA therapy: including hypersensitivity to the drug, personal history of pancreatitis, personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2, end-stage renal disease * Other active disease deemed not eligible to participant in the study according to treating physician * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
References
Publications (0)
Data not yet available